Contamination Rates in Duodenoscopes Reprocessed Using Enhanced Surveillance and Reprocessing Techniques: A Systematic Review and Meta-Analysis
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Background/Aims: Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminatedduodenoscopes. In 2015, the United States Food and Drug Administration recommended the following supplemental enhancedsurveillance and reprocessing techniques (ESRT) to improve duodenoscope disinfection: (1) microbiological culture, (2) ethyleneoxide sterilization, (3) liquid chemical sterilant processing system, and (4) double high-level disinfection. A systematic review andmeta-analysis was performed to assess the impact of ESRT on the contamination rates. Methods: A thorough and systematic search was performed across several databases and conference proceedings from inceptionuntil January 2021, and all studies reporting the effectiveness of various ESRTs were identified. The pooled contamination rates ofpost-ESRT duodenoscopes were estimated using the random effects model. Results: A total of seven studies using various ESRTs were incorporated in the analysis, which included a total of 9,084 post-ESRTduodenoscope cultures. The pooled contamination rate of the post-ESRT duodenoscope was 5% (95% confidence interval [CI]:2.3%–10.8%, inconsistency index [I2]=97.97%). Pooled contamination rates for high-risk organisms were 0.8% (95% CI: 0.2%–2.7%,I2=94.96). Conclusions: While ESRT may improve the disinfection process, a post-ESRT contamination rate of 5% is not negligible. Ongoingefforts to mitigate the rate of contamination by improving disinfection techniques and innovations in duodenoscope design toimprove safety are warranted.
Abstract
Background/Aims: Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminatedduodenoscopes. In 2015, the United States Food and Drug Administration recommended the following supplemental enhancedsurveillance and reprocessing techniques (ESRT) to improve duodenoscope disinfection: (1) microbiological culture, (2) ethyleneoxide sterilization, (3) liquid chemical sterilant processing system, and (4) double high-level disinfection. A systematic review andmeta-analysis was performed to assess the impact of ESRT on the contamination rates. Methods: A thorough and systematic search was performed across several databases and conference proceedings from inceptionuntil January 2021, and all studies reporting the effectiveness of various ESRTs were identified. The pooled contamination rates ofpost-ESRT duodenoscopes were estimated using the random effects model. Results: A total of seven studies using various ESRTs were incorporated in the analysis, which included a total of 9,084 post-ESRTduodenoscope cultures. The pooled contamination rate of the post-ESRT duodenoscope was 5% (95% confidence interval [CI]:2.3%–10.8%, inconsistency index [I2]=97.97%). Pooled contamination rates for high-risk organisms were 0.8% (95% CI: 0.2%–2.7%,I2=94.96). Conclusions: While ESRT may improve the disinfection process, a post-ESRT contamination rate of 5% is not negligible. Ongoingefforts to mitigate the rate of contamination by improving disinfection techniques and innovations in duodenoscope design toimprove safety are warranted.
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